Internet-based Talking About Risk and Adolescent Choices: Health and Emotion Regulation Options

NCT06894277 | Recruiting

• 2 other identifiers: 03464R42HD110333-02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Using the efficacious iTRAC intervention to enhance emotion regulation competencies as a foundation, this study will create and test iTRAC-HERO to teach emotion regulation skills in the context of sexual health education.

Conditions

Emotion Regulation; Adolescent Behavior; Risky Sexual Behavior

Keywords

Risky Sexual Behavior; Emotion Regulation; Adolescent Behavior

Outcome Measures

Primary Outcomes (2)

• Change in Sexual Self-Efficacy (SSE) from baseline to 6 months.

  The Sexual Self-Efficacy Scale (12 items) will measure self-efficacy for safer sexual activity as a main outcome which will indicate iTRAC-HERO's efficacy and ability to promote healthier sexual behaviors with the full sample (not just those who are sexually active).

  Baseline, 1 month post-intervention, 6 month follow up

• Change in Self Efficacy for HIV Prevention from baseline to 6 month.

  The Self-Efficacy for HIV Prevention Scale (12 items) assesses a range of behaviors related to prevention of HIV, other STIs, or unintended pregnancy, including refusing sexual behaviors, discussing sexual histories with partners, buying condoms, taking free condoms, carrying condoms, and asking a partner to use a condom.

  Baseline, 1 month post-intervention, 6 month follow up

Secondary Outcomes (4)

• Change in Sexual Risk Cognition from baseline to 6 months

  Baseline, 1 month post-intervention, 6 month follow up

• Change in attitudes towards abstinence from baseline to 6 months

  Baseline, 1 month post-intervention, 6 month follow up

• Change in frequency of sexual and substance use behaviors from baseline to 6 months

  Baseline, 1 month post-intervention, 6 month follow up

• Change in adolescent substance use behaviors from baseline to 6 months

  Baseline, 1 month post-intervention, 6 month follow up

Other Outcomes (5)

• Change in Emotion Regulation Skills from baseline to 6 months

  Baseline, 1 month post-intervention, 6 month follow up

• Change in frequency of dificulties with emotion regulation from baseline to 6 months

  Baseline, 1 month post-intervention, 6 month follow up

• Change in usage of emotion regulation behaviors taught in iTRAC-HERO from baseline to 6 months

  Baseline, 1 month post-intervention, 6 month follow up

Study Arms (2)

Waitlist Control

NO INTERVENTION

Control participants will be assessed on the same schedule as the treatment condition and offered the intervention after 6-month follow-up.

iTRAC-HERO

EXPERIMENTAL

iTRAC-HERO is an 8-module, web-based intervention for middle school boys and girls to complete. Its goal is primary prevention of adolescent sexual risk behaviors by targeting emotion regulation and sexual self-efficacy. (e.g., to refuse sexual advances).

Behavioral: iTRAC-HERO

Interventions

iTRAC-HERO BEHAVIORAL

iTRAC-HERO will consist of eight, approximately 45-minute, "gamified" digital modules of 4-6 activities (games, videos, etc.). No instruction is needed to use the program. Content will use gender- and sexuality-inclusive language and avoid heteronormative descriptions of risk. This content will include strategies for (and practice with) recognizing and managing emotions, particularly in relation to sexual health situations, to enhance the likelihood that the emotion regulation and sexual health education provided can be applied to experiences that are emotionally arousing and lead to risk.

iTRAC-HERO

Eligibility Criteria

• Age: 12 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Attending 7th grade
• Between 12 and 14 years old
• Parent/guardian speaks English or Spanish
• Attending participating school

You may not qualify if:

• Unable to read at a 4th grade level
• Have a sibling who has participated in the study
• Have a development disorder

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Klein Buendel, Inc.: lead
• Rhode Island Hospital: collaborator
• University of Oregon: collaborator

Study Sites (1)

Klein Buendel, Inc.

Golden, Colorado, 80401, United States

RECRUITING

MeSH Terms

Conditions

Emotional Regulation; Adolescent Behavior

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Officials

• Christopher Houck, PhD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Berteletti

CONTACT

3035654321; jberteletti@kleinbuendel.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Waitlist Control Trial

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 25, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): June 8, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: After analyses are completed for the aims of the study.
• Access Criteria: The data package will be available for future investigators. For datasets that include potentially sensitive information, investigators not part of the original study will submit requests to be reviewed by the PIs. Qualified investigators who agree to terms of use and confidentiality agreements will be provided with deidentified data.

Locations

US (1)